pulmonary vein isolation with versus without continued antiarrhythmic drug treatment in subjects with recurrent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to compare the efficacy and safety of pv isolation with continued antiarrhythmic drug treatment (pvi+adt) to pv isolation without continued adt (pvi-adt) in patients undergoing treatment for symptomatic recurrent af.

subjects that underwent pv isolation for paroxysmal or non-longstanding persistent af and are free of arrhythmia at the end of the 3-month blanking period while taking adt. eligible subjects who sign the study informed consent form will be randomized into one of two study arms: pvi+adt group: continue adt through 9 months follow-up pvi-adt group: no adt through 9 months follow up

Eligibility criteria:
inclusion criteria: * patient has continued (ic or iii) adt throughout the 3-month blanking * patient is free of symptomatic and asymptomatic af (as evidenced by 1-day holter) at the 3-month visit * drug-resistant (at least one class ic or iii) symptomatic af was the primary indication for prior pv isolation * in the three months prior to pvi, at least one episode of symptomatic or asymptomatic af * pv isolation was performed according to the standards set forward by the task force document (sedation or general anesthesia) * pv isolation was the only target for ablation (except for cavotricuspid (cti) ablation if documented afl) * pv isolation was performed by point-by-point irrigated radio frequency (rf) guided by contact-force (biosense) (10-30gr-continuous lesion) * pv isolation (i.e. entry block) was verified in each vein after a waiting time and adenosine (with continued rf if acute reconnection) * signed patient informed consent form. * age 18 years or older. * able and willing to comply with all follow-up testing and requirements. exclusion criteria: * longstanding persistent atrial fibrillation (\>12 months of continuous af) * previous ablation for af * left atrium (la) size \> 55 mm * left ventricular ejection fraction (lvef) \< 40% * af secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause * coronary artery bypass graft (cabg) procedure within the last six months * awaiting cardiac transplantation or other cardiac surgery * documented left atrial thrombus on imaging * diagnosed atrial myxoma * women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable) or breastfeeding * acute illness or active systemic infection or sepsis * unstable angina * uncontrolled heart failure * myocardial infarction within the previous two (2) months * history of blood clotting or bleeding abnormalities * contraindication to anticoagulation therapy (ie, heparin or warfarin) * life expectancy less than 12 months * enrollment in any other study evaluating another device or drug * presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction * patients not taking any class ic or iii adt at 3 months after pv isolation * no documentation of entry block at initial pv isolation - no waiting time or adenosine. * additional linear ablation or defractionation during the initial procedure (except for cti ablation for documented or induced cavo-tricuspid isthmus dependent flutter).